Techniques to Reduce the Severity and Frequency of Emergent Reactions

Not Applicable

Terminated

• Conditions: Analgesia

• Registration Number: NCT03832309
• Lead Sponsor: CHRISTUS Health

Brief Summary

The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.

Detailed Description

The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department.

The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A\&M medical school, and serves an inner-city population.

Study Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Be at least 18 years of age
• Required need for procedural sedation and analgesia

Exclusion Criteria

• Age< 18
• Hypertension
• Raised Intracranial pressure
• Major psychological disorders
• Procedures involving laryngel manipulations
• History of Laryngeal sapsm History of adverse reactions to ketamine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
STAI-6	24 months	To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.
T-Test	24 months	Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test,

Trial Locations

Locations (1)

CHRISTUS Health; 🇺🇸 Corpus Christi, Texas, United States